Memorandum 36 – Sponsored Research Financial Conflict of Interest Policy
Reviewed and approved July 26, 2012
Amended March 13, 2014
Norwich University is committed to fostering an environment in which the highest ethical standards in the conduct of research and other scholarly activities are followed, and complying with federal regulations governing that conduct. As such, the University is responsible for managing any actual or potential conflicts of interest that may arise due to the Financial Interests of an investigator (including the investigator’s spouse, legal partner, and dependent children). This policy explains possible areas of Financial Interest for sponsored research, describes the disclosure document that all researchers must complete, and details procedures to follow if a conflict arises.
Applicability of the Policy
This policy covers faculty, staff, and students who have research responsibilities in conjunction with their employment or in conjunction with a course of study, and any other persons who are required by law or federal regulation to be covered by an approved University policy regarding financial conflict of interest.
This policy was updated in July 2012 to put Norwich in compliance with the federal Department of Health and Human Service’s final rule of “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors,” 42 CFR Part 50, 45 CFR Part 94. Definitions are drawn from those rules and regulations published in the Federal Register on August 25, 2011, as they are similar in intent to the requirements of other external public or private entities. They now include lower financial disclosure thresholds, new conflict of interest training, new public accessibility requirements, and increased transparency for travel reimbursement.
Family means any member of the investigator’s immediate family, specifically any dependent children, spouse, or legal partner.
Financial Interest means anything of monetary value received or held by an investigator or an investigator’s family including, but not limited to, salary or other payments for services (e.g., consulting fees, honoraria, or paid authorships for other than scholarly work; any equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights and interests (e.g., patents, trademarks, service marks, and copyrights).
For investigators, Financial Interest also includes any reimbursed or sponsored travel related to his/her institutional responsibilities and which has been paid for by an entity other than US federal, state, or local governmental agencies, US institutions of higher education, academic teaching hospitals, and medical centers.
The term does not include:
- salary, royalties or other remuneration from the applicant’s institution;
- income from the authorship of academic and scholarly works;
- income from seminars, lectures, or teaching engagements sponsored by and service on advisory or review panels for a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; or
- equity interests or income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles.
Significant Financial Interest means a Financial Interest that reasonably appears to be related to the investigator’s institutional responsibilities, and:
- if with a publicly traded entity, the aggregate value of any salary or other payments for services received, or the value of any equity interest, during the 12-month period preceding the disclosure exceeds $5,000; or
- if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the 12-month period preceding the disclosure exceeds $5,000; or
- if with a non-publicly traded company, is an equity interest of any value during the 12-month period preceding or as of the date of disclosure; or
- is income related to intellectual property rights and interests not reimbursed through Norwich.
Financial Conflict of Interest means a Significant Financial Interest that Norwich reasonably determines could directly and significantly affect the design, conduct, and reporting of Institutional research.
Institutional responsibilities means the investigator’s responsibilities associated with his or her institutional appointment or position, such as teaching, research, clinical activities, administration, and institutional internal and external professional committee service.
Investigator means any individual who is responsible for the design, conduct, or reporting of external sponsored research, or proposals for such funding, which may also include collaborators and consultants. The rules for investigators also apply to SBIR/STTR Phase II applicants/awardees; Phase I SBIR/STTRs are exempt.
Research means a systematic investigation, study, or experiment designed to contribute to knowledge. The term encompasses basic and applied research as well as product development.
Each investigator must complete the Norwich University Financial Conflict of Interest Disclosure (PDF) form prior to submitting any proposal to an external funding source; newly hired investigators must also complete the form within 30 days of initial appointment or employment. This form must be updated for each sponsored project either annually or at any point when an investigator obtains any new reportable Significant Financial Interests.
Investigators must also disclose reimbursed or sponsored travel related to their institutional responsibilities, as defined above in the definition of Financial Interest. Such disclosures must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration and, if known, the monetary value. The Controller will determine if additional information is needed (e.g., the monetary value if not already disclosed) to determine if the travel constitutes a Financial Conflict of Interest with the investigator’s research.
The disclosure form is available in hardcopy at the Office of Academic Research, 325 Jackman Hall. A signed original should be sent to the Associate Vice President for Research, who will retain a copy for the proposal archives and forward the original to the Controller.
The Controller or official designee will review all disclosure statements to determine if a Financial Conflict of Interest exists. If so, the process detailed below will apply.
Management of Conflict of Interest
If the Controller determines that a potential conflict of interest exists, the Controller will work with the Senior Vice President for Academic Affairs (SVPAA) and the investigator to determine conditions or restrictions that could be put in place to manage, reduce, or eliminate that conflict. These measures could include the following:
- public disclosure of Significant Financial Interests;
- monitoring of research by independent reviewers;
- modification of the research plan;
- disqualification from participation in the portion of the externally-funded research that would be affected by Significant Financial Interests;
- divestiture of Significant Financial Interests; or
- severance of relationships that create conflicts.
In line with National Science Foundation guidelines, “if the reviewer(s) determines that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a Significant Financial Interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the reviewer(s) may allow the research to go forward without imposing such conditions or restrictions.” In these cases, the SVPAA will make the final decision regarding resolution.
If Norwich cannot satisfactorily manage a conflict of interest, its SVPAA shall notify the external funding agency’s general counsel in writing.
Collaborators, sub-awardees, and/or subcontractors from other organizations must either comply with this policy or provide proof that they are in compliance with federal policies regarding financial conflict of interest.
If an investigator violates either this policy or the terms of any resolution plan, the Controller will notify the SVPAA, who will impose sanctions or initiate disciplinary proceedings against the violating individual.
If bias is found, a report will be submitted to the investigator’s external sponsor in accordance with its regulations, including a description of the impact of bias on the research project and a plan of action to eliminate or mitigate the effect of the bias.
Every investigator must complete training on this policy prior to engaging in research and at least every four years, and immediately under the following circumstances:
- Institutional FCOI policy change in a manner that affects investigator requirements
- New employment by Norwich
- A finding that an investigator is non-compliant with Norwich’s FCOI policy or management plan
Norwich will maintain records of all financial disclosures and actions taken to resolve conflicts of interest for three years beyond the termination or completion of the grant to which they relate, or until the resolution of any sponsoring agency’s action involving those records, whichever is longer.
To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. However, Norwich may make such information available to an agency funding research of the faculty member, to a requestor of information concerning Financial Conflict of Interest related to the external funder, or to the primary entity who made the funding available to Norwich, if requested or required. If Norwich is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the investigator will be informed of this disclosure.
Prior to expenditure of funds, Norwich will publish on a publicly available website, or respond to a request within five business days, information about any Significant Financial Interest that meets the following criteria:
- The significant public interest was disclosed and is still held by the investigator
- A determination has been made that Significant Financial Interest is related to the externally-funded research; and,
- A determination has been made that the Significant Financial Interest is a financial conflict of interest